Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

Recruiting now · Not applicable

Conditions studied: PARKINSON DISEASE (Disorder)

In brief

Exercise is a primary intervention for symptom management in Parkinson's Disease (PD). However, challenges related to transportation, mobility, and socioeconomic factors often hinder consistent participation in exercise programs. To promote increased access and participation, remote exercise programs offer a promising solution. The investigators previously showed that laboratory-based, high-intensity resistance exercise improves sleep efficiency in individuals with PD in a randomized, controlled, clinical trial. The investigators aim to adapt this protocol for remote delivery and to evaluate the usability of a remote sleep-monitoring device in people with Parkinson's Disease (PwP). Guided by the IDEAS framework for digital health intervention design, the investigators will modify the exercise protocol to ensure safety, accessibility, and fidelity in a home setting. Specific aims include: (1) assessing the adaptability of the HIRE protocol for remote implementation through participant acceptability ratings, adherence, exertion levels, and safety outcomes, (2) evaluating the usability of the Waveband sleep monitoring headband and adherence to night wear schedules, and 3) gather qualitative feedback through semi-structured interviews to understand participant perspectives on protocol design, session completion, and safety. By integrating behavioral theory, participant engagement, and real-world constraints, this research will inform scalable, home-based interventions that are both effective and responsive to the lived experiences of PwP. The findings will lay the groundwork for future clinical trials and broader dissemination of remote therapeutic strategies in neurodegenerative care.

Key facts

Study ID

NCT07498296

Run by

University of Colorado, Denver

People needed

16

Starts

2026-03-05

Expected to finish

2026-11-15

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently residing in Colorado, USA
• PD diagnosis per Movement Disorders Society Diagnostic Criteria
• Requiring less than minimal assistance at home
• Having internet access
• Having a video-capable device

You may not qualify if…

• Uncontrolled cardiovascular disease or pulmonary disease
• Musculoskeletal injuries
• Participation in Parkinson's Disease community exercise programs more than 3 days a week
• Contraindication to physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
• Fall risk defined by requiring >20 seconds to complete the 5 times sit to stand test14 or high frequency of falls within the past year (≥ one fall per month)
• Virtual Montreal Cognitive Assessment (MoCA) score ≥ 18 (performed at the eligibility visit)

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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